TUSSIN DM COUGH PLUS CHEST CONGESTION- dextromethorphan hydrobromide and guaifenesin solution

Tussin DM by

Drug Labeling and Warnings

Tussin DM by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, Inc. DBA LEADER. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

Cough suppressant

Expectorant

INDICATIONS & USAGE

Uses

• ▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• ▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

WARNINGS

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• ▪ cough that occurs with too much phlegm (mucus)
• ▪ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

DOSAGE & ADMINISTRATION

Directions

• ▪ do not take more than 6 doses in any 24-hour period
• ▪ measure only with dosing cup provided
• ▪ keep dosing cup with product
• ▪ ml = milliliter
• ▪ this adult product is not intended for use in children under 12 years of age

• age:

  dose

• adults and children 12 years and over:

  20 ml every 4 hours

• children under 12 years:

  do not use

STORAGE AND HANDLING

Other information

• ▪ each 20 ml contains: sodium 8 mg
• ▪ store at room temperature. Do not refrigerate.

INACTIVE INGREDIENT

Inactive ingredients

anhydrous citric acid, carboxymethyl cellulose sodium, disodium edetate, flavors, glycerin, menthol, potassium citrate, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

QUESTIONS

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

COMPARE TO DYE-FREE SUGAR-FREE ADULT ROBITUSSIN® COUGH+CHEST CONGESTION DM® active ingredients*

LEADER™
NDC 70000-0713-1

Adult I Sugar-Free

Tussin DM

Cough+Chest
Congestion DM

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg

Cough Suppressant I Expectorant

•   Controls Cough
•   Relieves Chest Congestion
•   Thins & Loosens Mucus

Dye-Free

Specially
Formulated
for DIABETICS
Cherry Menthol Flavor

For Ages 12 & Over
8 FL OZ (237 ml)

100% Money Back Guarantee

Distributed by: CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to care™ since 1979

*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark DYE-FREE Sugar-Free Adult Robitussin Cough+chest Congestion DM.

INGREDIENTS AND APPEARANCE

TUSSIN DM  COUGH PLUS CHEST CONGESTION
dextromethorphan hydrobromide and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0713
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0713-1	1 in 1 CARTON	10/07/2024
1		237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/07/2024

Labeler - Cardinal Health 110, Inc. DBA LEADER (063997360)